Flex Pharma Reports Fourth Quarter and Fiscal 2018 Financial Results

On March 6, 2019 Flex Pharma, Inc. (NASDAQ: FLKS), reported its financial results for the three months and fiscal year ended December 31, 2018 (Press release, Flex Pharma, MAR 6, 2019, View Source [SID1234534031]).

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On January 3, 2019, Flex Pharma (the "Company") and Salarius Pharmaceuticals, LLC ("Salarius") entered into an Agreement and Plan of Merger (the "Merger Agreement") pursuant to which, among other things, Falcon Acquisition Sub, LLC, a wholly owned subsidiary of the Company, will merge with and into Salarius, with Salarius continuing as a wholly owned subsidiary of the Company and the surviving company. On February 14, 2019, the Company filed a registration statement on Form S-4 with the Securities and Exchange Commission that provides additional information related to the merger. The merger is expected to close in the first half of 2019. The Company continues to sell HOTSHOT, its consumer product that helps to prevent and treat exercise associated muscle cramps.

The Merger Agreement (i) values Flex Pharma at $10.5 million, subject to adjustment, on a dollar-for-dollar basis, based on Flex Pharma’s net cash balance at the closing of the merger compared to a target net cash of $3.3 million, and (ii) values Salarius at $36.6 million, subject to adjustment, on a dollar-for-dollar basis, based on the sale of Series A Preferred Units pursuant to subscription agreements that Salarius entered into prior to the Merger Agreement compared to the target sale of $7.0 million of Series A Preferred Units.

Under the Merger Agreement, immediately following the effective time of the merger, Flex Pharma’s current stockholders will own approximately 19.9% of the combined company, on a partially-diluted basis, and Salarius’ current members will own approximately 80.1% of the combined company, on a partially-diluted basis.

In addition, at or prior to the closing of the merger, Flex Pharma will pay a dividend of or distribute one right per share of the Company’s common stock to its stockholders of record as of a date and time determined by the Company’s board of directors. Each right will entitle such stockholders to receive a warrant to purchase shares of Flex Pharma’s common stock ("Warrant") six months and one day following the closing date of the merger.

The aggregate value of all of the Warrants to be issued to Flex Pharma’s stockholders generally represents the difference between (i) Flex Pharma’s value and (ii) the value of Flex Pharma’s common stock that Flex Pharma’s current stockholders will have in the combined company.

"We continue to make progress towards completing the merger with Salarius with the recent filing of our Registration Statement on Form S-4," stated William McVicar, Ph.D., Flex Pharma’s President and Chief Executive Officer. "We continue to believe that a merger with Salarius is the best opportunity for significant near- and long-term value creation for Flex stockholders. Salarius’ lead compound, Seclidemstat, is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study in Ewing sarcoma and Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers. We believe that Salarius could be poised to address significant unmet needs in oncology and we look forward to completing the merger with Salarius."

Fourth Quarter & Full Year 2018 Financial Results

Cash Position: As of December 31, 2018, Flex Pharma had cash and cash equivalents of $9.8 million. The Company held no marketable securities at December 31, 2018. During the three months ended December 31, 2018, cash and cash equivalents decreased by $3.1 million.
Total Revenue: Total revenue for the three months ended December 31, 2018 was approximately $163,000. Total revenue for the year ended December 31, 2018 was approximately $0.8 million, including approximately approximately $11,000 of other revenue.
Cost of Product Revenue: Cost of product revenue for the three months ended December 31, 2018 was approximately $75,000. There were no inventory write-offs during the three months ended December 31, 2018. Cost of product for the twelve months ended December 31, 2018 was approximately $431,000 and included inventory write offs of approximately $85,000.
R&D Expense: Research and development expense for the three months ended December 31, 2018 was $0.2 million and $11.9 million for the year ended December 31, 2018. Research and development expense for these time periods primarily included costs associated with the Company’s clinical operations and wind-down of FLX-787 Phase 2 clinical studies, personnel costs (including salaries, termination-related costs, retention-related costs and stock-based compensation costs) and external consultant costs.
SG&A Expense: Selling, general and administrative expense for the three months ended December 31, 2018 was $1.9 million and $10.6 million for the year ended December 31, 2018. Selling, general and administrative expense for this period primarily included personnel costs (including salaries, retention-related costs and stock-based compensation costs), fulfillment costs related to HOTSHOT, legal and professional costs, and external consultant costs.
Net Loss and Cash Flow: Net loss for the three months ended December 31, 2018 was ($2.0) million, or ($0.11) per share and included $0.2 million of stock-based compensation expense. For the year ended December 31, 2018, net loss was ($21.9) million, or ($1.22) per share and included $1.9 million of stock-based compensation expense. As of December 31, 2018, Flex Pharma had 18,067,392 shares of common stock outstanding. The net loss for the fourth quarter of 2018, as well as for the year ended December 31, 2018, was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with HOTSHOT, and general and administrative costs.

Savara To Report Q4/Year-End 2018 Financial Results And Business Update On March 13, 2019

On March 6, 2019 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported it will release its fourth quarter and year-end 2018 financial results on Wednesday, March 13, 2019 (Press release, Savara, MAR 6, 2019, View Source [SID1234534029]). Savara management will also host a conference call for investors at 5:30 p.m. ET/2:30 p.m. PT on Wednesday, March 13, 2019 to discuss its fourth quarter and year-end 2018 financial results and provide a business update.

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Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through March 20, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10128884.

CymaBay Announces Pricing of Public Offering of Common Stock

On March 6, 2019 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported the pricing of its previously announced underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $12.50 per share, before underwriting discounts and commissions (Press release, CymaBay Therapeutics, MAR 6, 2019, View Source [SID1234534028]). All of the shares of common stock are being offered by CymaBay. In addition, CymaBay has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock at the public offering price less underwriting discounts and commissions. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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The offering is expected to close on March 8, 2019, subject to the satisfaction of customary closing conditions.

Citigroup, Evercore ISI and Cantor Fitzgerald & Co. are acting as the joint book-running managers for the offering. Oppenheimer & Co. Inc. and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and the accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

CRISPR Therapeutics to Participate in Upcoming Investor Conferences

On March 6, 2019 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to make the following presentations later this month (Press release, CRISPR Therapeutics, MAR 6, 2019, View Source [SID1234534027]):

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Barclays Global Healthcare Conference
Date: Wednesday, March 13, 2019
Presentation: 10:15 a.m. ET
Location: Miami, FL

Oppenheimer’s 29th Annual Healthcare Conference
Date: Wednesday, March 20, 2019
Presentation: 1:35 p.m. ET
Location: New York, NY

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following each presentation.

Syndax to Present at the Cowen 39th Annual Health Care Conference

On March 6, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will present at the Cowen 39th Annual Health Care Conference on Wednesday, March 13, 2019 at 11:20 a.m. ET at the Boston Marriott Copley Place (Press release, Syndax, MAR 6, 2019, http://ir.syndax.com/news-releases/news-release-details/syndax-present-cowen-39th-annual-health-care-conference [SID1234534026]).

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A live webcast of the Company’s presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.